Clinical Trial

Study of Intracerebroventricular Injections of Autologous Adipose-Derived Stem Cells (RB-ADSCs) in Participants With Mild-Moderate Alzheimer's Disease

Not Yet Recruiting Phase 2
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Summary
The goal of this Phase 2 clinical trial is to learn if repeated dosing of RB-ADSC (an investigational autologous cell product obtained from participant's own adipose tissue) enhances the positive preliminary results seen in Phase 1 for the of treatment for mild to moderate Alzheimer's Disease in adults. The clinical trial will also continue to evaluate the safety of repeated dosing of RB-ADSC. This study will primarily evaluate the effects of repeated dosing of RB-ADSC on cognitive performance compared to placebo control. Participants will receive RB-ADSC every 2 months for a total of 6 doses. Participants randomized into the placebo control group will have the option to cross over to receive treatment after completion of the primary phase of the study.
Trial Details
NCT Number NCT07205601
Lead Sponsor Regeneration Biomedical, Inc.
Conditions Alzheimer Disease
Enrollment 115 participants
Start Date 2025-11
Primary Completion 2028-03 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2025-10-03